Dual component oral composition for enhancing remineralization of teeth

ABSTRACT

An dual oral composition is provided having a first peroxide-containing component and a second bicarbonate-containing component having exceptional anti-plaque and antibacterial action with re-mineralization properties

FIELD OF THE INVENTION

The present invention relates to a dual composition dentifrice, moreparticularly to a composition of dentifrice that achieves significanteffects for preventing dental caries and periodontal disease.

THE RELATED ART

Tooth decay, or dental caries, is an infectious disease, the key featureof which is an increase within dental plaque of aerobic bacteria such asStreptococcus Mutans and Lactobacillus coming in contact with sugar.Tooth decay is an infection which results in the demineralization of thehard tissues. If left untreated, the disease causes increasedhypersensitivity, pain and ultimately death of the tooth as theinfection reaches the softer, interior part of the tooth called thepulp. Demineralization occurs when carbohydrates, especially sugar, iseaten, producing organic acids and the acids come in contact with thetooth structure. When enough acid is produced so that the pH goes below5.5, the process begins. Teeth are porous allowing acidic fluids to comein contact not only with enamel, which is above the gums, but also thecementum, which is the tooth surface normally below the gum line. Whendemineralization occurs, those pores become larger, forming cavitieswithin the tooth structure. Remineralization is the process in whichminerals are returned to the molecular structure of the tooth itself.

Periodontal disease is also an infectious disease that attacks thesupporting structures that surround the teeth, namely bone, connectiveand gum tissue. The bacteria responsible for periodontal disease areanaerobic, and they thrive in an acidic, oxygen-free environment, In thepresence of sugar, the anaerobic bacteria use that sugar and excrete astrong acid as a by-product of the metabolism of the sugar. In responseto the toxic nature of the acid, the gum tissue becomes very inflamedand begins to pull away from the side of the tooth and root surface. Asthe gums pull away from the tooth and root surfaces, spaces are formed,called “pockets”. Bacterial toxins and the body's natural response toinfection start to break down the bone and connective tissue that holdteeth in place. If not treated, the bones, tissue and gums that supportthe teeth are destroyed, which can eventually lead to teeth becomingloose and having to be removed.

The present invention provides for a new composition that enhances theremineralization process inhibiting tooth decay, and it neutralizes andoxygenates the periodontal environment eliminating the furtherance ofthe periodontal disease process.

SUMMARY

An oral composition is provided including a bicarbonate and peroxidecomponent. Accordingly, it is an object of the present invention toprovide a dual component Composition that enhances the remineralizationprocess of tooth enamel and cementum, Wherein tooth decay is prevented,and it also provides a neutral, oxygenated environment so thatperiodontal disease is also prevented. These and other objects of thepresent invention will become more readily apparent throughconsideration of the following summary and detailed description.

BRIEF DESCRIPTION OF DRAWINGS

FIG. 1 illustrates a normal tooth;

FIG. 2 illustrates a diseased tooth;

FIG. 3 illustrates the results of several patients that used theformulation;

FIG. 4 illustrates the formulation of the gel component of thecomposition;

FIG. 5 shows the formulation of the paste component of the composition;

FIG. 6 illustrates the hypersensitivity level of several patients thatused the formulation; and

FIG. 7 illustrates the tartar buildup of the patients.

DETAILED DESCRIPTIONS

The present invention comprises a dual component oral composition forthe prevention of tooth decay and periodontal disease. The dualcomposition comprises a first cleansing agent base gel and a secondsodium bicarbonate paste. The dual composition is used in conjunctionwith one another in a 1:1 ratio. Beyond the first essential ingredientof hydrogen peroxide of the first component there will also be includeda pharmaceutical acceptable carries including surfactant, humectants,thickening agent and sweeteners. The bicarbonate component containsxylitol and prescription strength neutral sodium fluoride. The xylitolis a non-fermentable sugar alcohol which has been shown to not onlyreduce dental decay significantly, but also has re-mineralizationcapability in combination with other ingredients in the bicarbonatecomponent. Xylitol has an alkaline makeup which inhibits anaerobicbacteria. The neutral sodium fluoride also re-mineralizes the toothsurface and prevents decay. The peroxide component provides oxygen to bereleased when introduced to the bicarbonate component and water isintroduced.

The oxygen released inhibits the anaerobic bacteria that must live in anoxygen-free environment. Additionally, the bicarbonate component isbasic in nature and neutralizes the harmful acidic environment, and onceagain the anaerobic bacteria cannot survive in a non-acidic environment.The salt or sodium chloride within the component reduces theinflammation of the gum tissue as well as inhibits the anaerobicbacteria during osmosis. These three properties provided by theformulation of the present invention oxygenation, neutralization andosmosis reverse the environment conducive to periodontal disease.

The present invention comprises a dual component oral composition forthe prevention of tooth decay. The dual composition comprises a firstcleansing agent base gel and a second sodium bicarbonate paste. The dualcomposition is used in conjunction with one another in a 1:1 ratio.

The cleansing agent of the first component is a peroxide compound,preferably hydrogen peroxide. Beyond the first essential ingredient ofhydrogen peroxide of the first component there will also be includedpharmaceutical acceptable carries including surfactant, humectants,thickening agent and sweeteners.

Peroxide Gel Cleansing Agent

A first essential component or cleansing agent of compositions accordingto the present invention is that of a peroxide compound. In thiscomposition as shown in FIG. 3, hydrogen peroxide of approximately 7.5%by weight.

Polysorhate 20 NF is the surfactant which can be incorporated to providefoaming properties. Sorbitol Solution USP 70% by weight is the humectantor wetting agent which prevents the water in the composition fromevaporating.

Sweetness and flavoring agents can be used to ensure good taste duringtooth brushing or for a freshening aftertaste after toothbrushing. Inthis gel component, Saccharin Sodium USP Dihydrate is the sweetener andMethyl Salicylate NF and Peppermint Oil are the flavorings. Poloxamer407 25% gel is the thickening agent. Hydrogen peroxide is the preferredessential cleansing agent which ranges about 7.5% by weight.

Method of Preparation of Hydrogen Peroxide gel

In an appropriate container mix saccharin sodium and polysorbate 20 insorbitol Solution until completely dissolved. Then add flavoring to theabove mixture. Add hydrogen peroxide to the mixture and place in an icebath until uniform mixture is formed. Transfer mixture to containers andlet stand at room temperature.

Method of Pre Titration of the Potassium Sorbate Gel

Mix Potassium Sorbate and Poloxamer 407 25% gel in a container and bringto final volume with cold refrigerated purified water. Refrigerateresultant mixture when all granules of potassium sorbite are mixedthoroughly and it takes up to 12 to 24 hours within the refrigeratorbefore the mixture becomes a clear solution. Once the mixture becomes aclear solution, the gel will solidify at room temperature.

Second Component

The second oral composition comprises the following essential compounds:Sodium Bicarbonate, Xylitol, and a re-mineralization agent includingCalcium Carbonate or Calcium Phosphate or, Dibasic USP Anhydrous ofequivalent percentage of weight. Along with these compounds, thecomposition will also include sodium chloride (salt), flavorings, and athickening agent. Polysorbate 20 NF is the thickening agent and theflavorings include Spearmint oil or peppermint oil, citric acid USPmonohydrate powder, marshmallow, stevioside 15% liquid extract, andspearmint powder. Sweetener is Xylitol in this component.

A second essential component of compositions is that of sodiumbicarbonate with a preferred weight of 25%.

A third essential component of compositions according to the presentinvention is xylitol which is 0.1% by weight. Xylitol is anon-fermentable sugar alcohol which has dental health benefits in cariesprevention. It has a plaque-reducing effect that attracts and starvesharmful micro-organisms, allowing the mouth to re-mineralize damagedteeth with less interruption. Xylitol specifically inhibits thestreptococci mutans group. It inhibits streptococci mutans in thepresence of other sugars with the exception of fructose. Salivacontaining xylitol is more alkaline than saliva which contains othersugar products. When saliva is alkaline, the calcium and phosphate saltsin saliva start to precipitate into those parts of enamel where they arelacking thereby allowing the tooth to effectively remineralize.

A fourth essential component of compositions is sodium fluoride that is1.1% by weight. The humectant sugar alcohol solution is optimally 10.5%by weight. This is a remineralization agent.

A fifth essential compound of the present invention is calcium carbonatewhich is preferably 25% by weight. This is a re-mineralization agent. Analternative re-mineralization agent is calcium phosphate, Dibasic USPAnhydrous.

The oral composition of the present invention for the hydrogen peroxidegel can be prepared in the preferred embodiment as described below inFIG. 4.

The oral composition of the present invention for the sodium bicarbonatepaste can be prepared in the preferred embodiment as described below inFIG. 5.

Method of Preparation of Sodium Bicarbonate Paste

At room temperature, in a container, with a mortar and pestle, triturateSodium Bicarbonate, Sodium Chloride and Calcium Carbonate together. Thenwet with enough glycerin until a thick smooth paste is formed. Then addflavorings and levigate thoroughly.

FIG. 1 depicts a cross-sectional view of a normal tooth. As shown, thegums (60) are attached by the gingival fibers to the surface of theenamel (45) and the space created by the side of the tooth and the gumtissue is the gingival crevice (55). Enamel (45) is a hard whitesubstance covering the crown of the tooth. The pulp (65) is the centralpart of the tooth that includes the living blood vessels and sensorynerves (75) that extend into the root (80) of the tooth near the bone(85) and out into the surrounding bone and enables sensation within thetooth. The gingiva or the gum tissue (60) is the tissue that lies overthe bone (85) around and between the teeth. Cementum (70) is thecalcified substance covering the root (80) of the tooth. Dentin (50) isthe calcified substance lying below the enamel (45) covering the pulp(65).

FIG. 2 depicts a cross-sectional drawing of an illustration of adiseased tooth. Depicted in FIG. 2 the gingival fibers have detachedfrom the surface of the enamel (45) of the diseased tooth forminggingival crevice (55). Plaque is present that has formed at the gumlineand below the gumline. Caries, or decay, has formed within the enamel(45) of the tooth. An infection or abscess (30) is shown at the tip ofthe root and infection is shown within the root of the tooth.

The applicant used the formulation in FIGS. 4 and 5 on various patientswith the results shown in FIGS. 3, 6 and 7. Prior to using theformulation, several of the patients had diseased gums at variousstages. After using the formulation, their gums, or periodontalcondition, improved significantly and showed significant signs ofre-mineralization. The level of detachment of the gums showedsignificant signs of re-attaching, improving to within normal limitswith a gingival crevice (55) of 3 mm or less as shown in FIG. 3 and lesstarter buildup as shown in FIG. 7. FIG. 6 show the decrease inhypersensitivity of the patients that used the formulation in FIGS. 4and 5.

What is claimed is:
 1. A dual-component oral composition comprising agel component comprising a cleansing agent and a humectant sugaralcohol; and a paste compound comprising sodium bicarbonate; sodiumfluoride, xylitol, and a re-mineralization agent selected from the groupconsisting of calcium carbonate and calcium phosphate, wherein there-mineralization agent and xylitol work in combination to reducehypersensitivity or periodontal pocketing.
 2. The dual-component oralcomposition of claim 1 wherein the cleansing agent is hydrogen peroxide.3. The dual-component oral composition of claim 1 wherein the humectantsugar alcohol is sorbitol.
 4. The dual-component oral composition ofclaim 1 further comprising polysorbate
 20. 5. The dual-component oralcomposition of claim 1 further comprising sweeteners.
 6. Thedual-component oral composition of claim 1 further comprising flavoring.A method of reducing dental hypersensitivity comprising brushing withthe dual-component oral composition of claim
 1. 8. A method of reducingperiodontal pocketing comprising brushing with the dual-component oralcomposition of claim 1.